From Lynn Clyde, BRC Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 QMS for clause 6.3 Infrastructure. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 6.3
“The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).”
There was an extensive preventive maintenance program in place. When the auditor reviewed the maintenance work sheets, he found that the maintenance schedule had been changed to a less frequent schedule on a few of the machines. Upon inquiring about this, the maintenance manager said that they did an analysis of the data and they have never had a breakdown on those machines, so they decided they did not need to perform the maintenance as often. The auditor felt they needed to stick to the original schedule which was based on the manufacturer’s recommendation.
It is up to each organization to determine the frequency and amount of maintenance that is required on their machines. This should be based on a number of factors, such as: manufacturer’s recommendations, industry standards, sensitivity of the machines, their impact on conformance of the product, historical data, etc. As long as the maintenance schedule is based on one or more of these factors, this should be acceptable. Furthermore, there is no requirement to document and record the maintenance system, but it is strongly recommended. Otherwise it is difficult to show evidence that the system is being followed and is meeting requirements.